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ADVR Reports Positive Preliminary Results of AVR118 Clinical
Trial in AIDS Patients Suffering from Body Wasting (Cachexia)
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10 November 2003, 08:21am ET
Patients Show Improved Appetite, Weight Stability or Gains,
and Enhanced Quality of Life
YONKERS, N.Y., Nov. 10 /PRNewswire-FirstCall/ -- Advanced
Viral Research Corp. (BB:ADVR) today reported that preliminary
results from the first 15 cachectic (wasting) AIDS patients
treated with the Company's novel immunomodulator AVR118 showed
improvement in appetite, weight gain or stability, and enhanced
quality of life in all the patients. None of the 15 patients
reported any significant side effects from AVR118 (formerly
known as Product R) therapy. Cachexia is a state of body
malnutrition and wasting with loss of body fat and lean body
weight.
The 15 patients who completed the trial included eight males,
five on highly active antiretroviral therapy (HAART), and seven
females, five of whom were receiving HAART. The primary
indication of the trial is the treatment of cachexia (body
wasting). The patients are part of a Phase I/Phase II open-
label dose escalation clinical trial being conducted at The
Kaplan Medical Center in Rehovot, Israel.
"We have taken the unusual step of publicizing these
preliminary results, despite the small population of patients,
because of the apparent strong clinical results demonstrated,
even in this short course treatment protocol, by AVR118 in these
very ill patients," said Eli Wilner, Chairman of the Board of
ADVR. "If the continuation of the study confirms these
preliminary findings, the value of AVR118 in treating body
wasting in AIDS patients will merit much broader scientific
analysis in a large study of AIDS patients."
"These preliminary results are very encouraging because a
positive clinical effect was seen in virtually all patients
following initiation of treatment with AVR118, even at the
lowest dosage," said James D'Olimpio, M.D., Director of the
North Shore University Hospital's Supportive Oncology and
Palliative Care Service, and a member of ADVR's Scientific
Advisory Board. "The study design and quality of data is worthy
of a presentation at an appropriate international scientific
meeting. I would encourage the investigators to prepare an
abstract once the statistical analysis of the data set is
completed so that these promising preliminary results can be
shared with the global scientific community." Dr. D'Olimpio has
done extensive research on cachexia, particularly in cancer
patients.
Mentioned Last Change
ADVR 0.22 0.01dollars or (4.76%)
When completed, the clinical trial will include a total of 30
patients, with 10 each receiving AVR118 administered
subcutaneously per day at the three doses of 0.4 ml, 2 ml, and 4
ml. The trial protocol specifies a two-week preliminary
observation period followed by four weeks of AVR118 therapy and
four weeks of observation.
"The preliminary results demonstrate the potential utility of
AVR118 in this group of patients," said Richard A. Guarino,
M.D., ADVR's clinical and regulatory advisor.
"These preliminary results in cachectic AIDS patients are
encouraging, and I eagerly await possible confirmation of our
preliminary results once all 30 patients have completed the
trial," said Shalom Z. Hirschman, M.D., ADVR's Chief Scientist.
"These results garnered midway through the clinical trial appear
to validate our expectations of the clinical activity of the
unique immunomodulator AVR118."
ADVR's AVR118 represents a biopolymer chemistry that possesses
novel immunomodulator activity. This peptide-nucleic acid, which
to date has shown no indication of human toxicity, appears to
stimulate the proinflammatory responses required to combat viral
infections such as AIDS and human papilloma virus and to dampen
aberrant autoimmune-type inflammatory responses, such as occur
in patients with rheumatoid arthritis. Therefore, AVR118 has
been termed a "switch-type" immunomodulator. AVR118 is in
clinical trials in Israel for the treatment of cachexia (body
wasting) in patients with AIDS.
For further information regarding Advanced Viral Research
Corp., please visit our website at www.adviral.com .
Advanced Viral Research Corp., based in Yonkers, New York, is
a biopharmaceutical firm dedicated to improving patients' lives
by researching, developing and bringing to market new and
effective therapies for viral and other diseases.
Note: This news release contains forward-looking statements
that involve risks associated with clinical development,
regulatory approvals, including application to the FDA, product
commercialization and other risks described from time to time in
the SEC reports filed by the Company. AVR118 (Product R) is not
approved by the U.S. Food and Drug Administration or any
comparable agencies of any other countries. There is no
assurance that the Company will be able to secure the financing
necessary to continue and/or complete the clinical trials of
AVR118 or satisfy certain other conditions relating to clinical
trials including obtaining adequate insurance on terms
acceptable to the Company or that if completed, clinical trials
performed outside the United States will assist the Company in
obtaining FDA or other regulatory approval. The Company
undertakes no obligation to update or revise the information
contained in this announcement whether as a result of new
information, future events or circumstances or otherwise.
Contact:
Eli Wilner
914-376-7383
SOURCE Advanced Viral Research Corp.
-0- 11/10/2003
/CONTACT: Eli Wilner, +1-914-376-7383, for Advanced Viral
Research Corp./
/Company News On-Call:
http://www.prnewswire.com/comp/903002.html/
/Web site:
http://www.adviral.com/
(ADVR)
CO: Advanced Viral Research Corp.
ST: New York
IN: MTC HEA BIO OTC
SU:
(Voluntary Disclosure: Position-
Long; LT Rating- Strong Buy)
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